Design Assurance Engineer
3 days ago
Design Assurance Engineer - Galway Our Galway based client are now recruiting for a Design Assurance Engineer to join their team. This role offers an excellent opportunity to work with a world leading Medical Devices company and great career progression opportunities. Purpose Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Support the application of Design Controls and Regulations in Sustaining Engineering and Product Development ensuring that we continue to deliver products of the highest safety and quality to our patients. Responsibilities Familiarity with requirements and procedures that govern medical device production and Design Control Understanding of Design Assurance requirements to support marketed product, product development, design changes and technology transfers and to ensure activities comply to all internal and regulatory requirements. Interfaces with Operations teams, R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing quality and technical input. Provides design quality support and product assembly knowledge in the resolution of PIRs, complaints investigation, CAPAs, non-conforming product, VIPs and regulatory requirement changes. Supporting transition to EU MDR by collaborating with submissions, reviewing notified body feedback, assisting divisional product teams with submission responses, and acting on feedback trends by driving process improvement projects across the design controls sub-processes Provide detailed assessments of impacts for design and process changes on commercialized products Acts as an inclusive team member in drawing conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities Support internal and external audits and audit responses for commercialized and new products. Collaborate in development and execution of Design Verification plans, protocols and reports for new and commercialized products as a member of multi-functional team activities through the life cycle of the product from concept, development, commercialization and end of life phases Assure quality and completeness of documentation associated with design verification studies (including test data, manufacturing records, investigations and deviations) and generate submission packages in conjunction with Project Teams and Regulatory Affairs for regulatory submissions. Coordinate and contribute with test laboratories and teams for product investigations, OOS, OOT and protocol deviations Ensure and maintain regulatory compliance with appropriate guidance documents, - company SOP/WIs, cGMPs, EU/FDA/Global and ICH guidelines for design verification activities. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Requirements: NFQ Level 8 qualification in aSTEMdiscipline (Science, Engineering) Minimum1-3 years experience in a Design Assurance capacity. Good technical capabilities, communication skills, teamwork abilities and initiative. Proven ability to work well both as part of a team but also able to work on own with minimum supervision. Proven ability to work well as part of a team & on own with minimum supervision. For more information on this excellent opportunity get in touch with Gary Keane Call: Email: Skills: Design quality problem solving quality engineer
-
Design Assurance Engineer
2 weeks ago
Galway, Ireland Cregg Recruitment Full timeDesign Assurance Engineer - Galway Our Galway based client are now recruiting for a Design Assurance Engineer to join their team. This role offers an excellent opportunity to work with a world leading Medical Devices company and great career progression opportunities. Purpose Demonstrates commitment to the Quality Policy (patient safety and product quality)...
-
Design Assurance Engineer
2 weeks ago
Galway, Ireland Abbott Laboratories Full timeAbout Abbott At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life....
-
Quality Engineer
1 week ago
Galway, Ireland Cregg Recruitment Full timeJob Title: Quality Engineer II (Design Assurance) Location: Galway-Permanent Industry: Medical Device Company information: Galways world leading medical device manufacturer Role Profile Working under the Principal Engineer this role is ideal for candidates from a strong R&D or MDR background who want to focus on Design Assurance. This role will be 20%...
-
Quality Engineer
3 days ago
Galway, Ireland Cregg Recruitment Full timeJob Title: Quality Engineer II (Design Assurance) Location: Galway-Permanent Industry: Medical Device Company information: Galways world leading medical device manufacturer Role Profile Working under the Principal Engineer this role is ideal for candidates from a strong R&D or MDR background who want to focus on Design Assurance. This role will be 20%...
-
Design Assurance Engineer II
3 days ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team. The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety,...
-
Design Assurance Engineer II
2 weeks ago
Galway, Ireland Aerogen Ltd Full timeAbout Aerogen: Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to...
-
Senior Design Assurance Engineer
2 weeks ago
Galway, Ireland Life Science Recruitment Full timeSenior Design Assurance Engineer Our client, a medical device company, is currently seeking a Design Assurance Engineer to join their team. The Design Assurance Engineer will be working in the Quality Assurance/Regulatory Affairs department responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process...
-
Senior Design Assurance Engineer
2 weeks ago
Galway, Ireland Abbott Laboratories Full timeAbout Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities...
-
(3 Days Left) Design Assurance Engineer II
2 weeks ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team. The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety,...
-
Senior Design Quality Engineer
2 weeks ago
Galway, Ireland CK Group Full timeSenior Design Quality Engineer Overview: CK QLS are recruiting a Senior Design Quality Engineer, to join our clients team for a 12-month project with potential extension. The role will be based in a hybrid setting in Galway, Ireland, with 3 days on-site work per week. The ideal candidate will have 5-8 years of experience in Quality Assurance for medical...
-
Civil Design Engineer
2 weeks ago
Galway, Ireland Cornhouse Consulting Full timeCompany Details:This consultancy is renowned for its expertise in Civil, Structural, and Traffic Engineering, particularly in Timber Frame Structural Engineering and Traffic Design Services. It provides comprehensive, cost-effective solutions with a skilled team of Chartered Engineers, Senior Engineers, CAD Technicians, and Administrative Staff, ensuring...
-
R&D Design Engineer
2 weeks ago
Galway, Ireland Merit Medical Ireland Ltd Full timeWhy Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. SUMMARY OF DUTIES Performs routine and complex technical...
-
Civil Design Engineer
1 week ago
Galway, Ireland Access Talent Group Full timeAccess Talent Group is thrilled to partner with a rapidly growing engineering consultancy based in Dublin, Cork, Galway and Castlebar in their search for a talented Civil Design Engineer to join their dynamic team. Our client is an industry leading engineering consultancy known for excellence, sustainability, and innovation. Their projects positively impact...
-
R&D Design Engineer
1 week ago
Galway, Ireland Sigmar Recruitment Full timeR&D Design Engineer About Your New Employer The company is a leader in the development of innovative medical devices that improve lives. They focus on creating cutting-edge solutions that enhance patient outcomes and contribute to advancements in healthcare. About Your New Job as an R&D Design Engineer Independently apply technical techniques, procedures,...
-
R&D Design Engineer
3 days ago
Galway, Ireland Sigmar Recruitment Full timeR&D Design Engineer About Your New Employer The company is a leader in the development of innovative medical devices that improve lives. They focus on creating cutting-edge solutions that enhance patient outcomes and contribute to advancements in healthcare. About Your New Job as an R&D Design Engineer Independently apply technical techniques, procedures,...
-
Senior Labelling Engineer
2 weeks ago
Galway, Ireland Abbott Laboratories Full timeAbout Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities...
-
Design Engineer – Building
2 weeks ago
Galway, Ireland TOBIN CONSULTING ENGINEERS Full timeTOBIN, a large multi-disciplinary (engineering, environmental, planning) consultancy practice operating in Ireland since 1952, is currently looking to recruit an ambitious and self-driven Design Engineer to join our busy and growing team in our Limerick Office. The position of Design Engineer within TOBIN requires a minimum Level 8 Honours Degree...
-
Senior Quality Engineer
23 hours ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational based here in Galway are looking to hire a Senior Quality Engineer on an initial 12-month contract. The Role: You will be based in the Coronary/RDN Post Market Design Assurance Department, partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products,...
-
Senior Quality Engineer
11 hours ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational based here in Galway are looking to hire a Senior Quality Engineer on an initial 12-month contract. The Role: You will be based in the Coronary/RDN Post Market Design Assurance Department, partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products,...
-
Commissioning & Design Engineer
2 weeks ago
Dublin, Cork, Galway, Ireland Access Talent Group Full timeAccess Talent Group are working with one of Ireland’s Specialist Electrical Engineering Companies who are currently seeking an experienced (3+ years) Commissioning & Design Engineer to join their expanding teams in Cork, Dublin or Galway to manage the design and pre-commissioning of TSO/DSO stations and associated IPP substations nationwide. This is an...
